6. Support the compliance of the Corrective and Preventive Action and Supplier Corrective Action system including the timeliness of processing CAPA’s and SCAR’s. Maintenance of all CAPA and SCAR files, coordinating efforts with the owners and managers; ensuring compliance with applicable regulations.

9. Coordinate and perform activities to ensure that all calibration and maintenance is completed for tools and instruments as needed. Maintain the Preventive Maintenance and Calibration files and database.

10. Notify personnel of training requirements and enter training data into the training tracker. Run training compliance reports, follow up with personnel and escalate as appropriate to ensure timely training. Coordinate and support activities to maintain a compliant in-house training program.

11. Establish and maintain external Standards document system.

12. Support Internal Audit Process including, compliance to Internal Audit schedule, and the monitoring of timely closure of findings.

13. Complete projects in an aggressive manner consistent with corporate objectives. Take an active role in determining day-to-day tasks.

14. Support company goals and objectives, policies and procedures, Quality System Regulation, and FDA/MDD regulations.

15. Maintain a professional, credible image with suppliers, co-workers, consultants, and other stakeholders that influence product development and acceptance.

16. Willingness to travel to vendor sites as required.

17. Maintain knowledge of current methods and techniques used in manufacturing.

? Ability to work independently, using good judgment, initiative and analytical abilities.

? Ability to work as a team member and ability to be very flexible, adaptable, and to work under pressure.

? Requires above average reading, verbal and written communications and presentation skills.

? Must be a friendly, helpful person who enjoys contact with employees and external contacts at all levels; must have the ability to engage people in conversations; and good listening skills.

? Self-motivated and self-directed; conscientious approach to work assignments; enjoys the challenges of multitasking and working at a fast pace while staying flexible to shift tasks frequently.

? Excellent interpersonal and negotiating skills; ability to adapt to changing work priorities; and ability to maintain good working relationships while dealing appropriately with sensitive and confidential matters and with a wide variety of personal and telephone contacts.

? Regular and punctual attendance and dependability in meeting commitments and deadlines are essential functions of this position.

? Proficiency in business English and grammar; good arithmetic skills and attention to detail to maintain records and process reports.

? Must be available and willing to work flexible schedules, as needed.

The above statements are intended to describe the general nature and level of work being performed. They are not intended to be construed as an exhaustive list of all responsibilities.